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Normobaric Oxygen (NBO) Therapy in Acute Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01542307
First received: February 21, 2012
Last updated: February 3, 2017
Last verified: February 2017
  Purpose
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Condition Intervention Phase
Migraine Biological: Oxygen Biological: Room air Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Normobaric Oxygen (NBO) Therapy in Acute Migraine

Resource links provided by NLM:


Further study details as provided by Aneesh B. Singhal, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) [ Time Frame: From baseline (0 minutes) to 30 mins ]

    The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.



Secondary Outcome Measures:
  • Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) [ Time Frame: Baseline (0 minutes) to 15 minutes ]

    The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.


  • Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) [ Time Frame: Baseline (0 minutes) to 60 minutes ]

    The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.


  • Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.


  • Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.


  • Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.


  • Final Nausea Score 0-1 on the Visual Analog Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.



Other Outcome Measures:
  • Post-gas Therapy Medication Use [ Time Frame: 60 minutes ]
    The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.


Enrollment: 22
Study Start Date: July 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
Biological: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
Placebo Comparator: Room Air
Medical air inhaled for 30 minutes during migraine attack
Biological: Room air
Placebo

Detailed Description:
A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with frequent migraine (at least 1 attack per month)

Exclusion Criteria:

  • Secondary (non-migraine) headache
  • Chronic obstructive pulmonary disease
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542307

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aneesh B Singhal, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Aneesh B. Singhal, MD, Associate Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01542307     History of Changes
Other Study ID Numbers: 2009P000380
2009P000380 ( Other Identifier: PHRC )
Study First Received: February 21, 2012
Results First Received: October 16, 2016
Last Updated: February 3, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Aneesh B. Singhal, MD, Massachusetts General Hospital:
migraine
oxygen therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 27, 2017